COACT Study: CGRPmAbs + OnabotulinumtoxinA Assessment of Chronic Migraine Treatments Study

NCT05724771 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 2020-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic migraine patients treated with OnabotulinumtoxinA may experience breakthrough headaches, especially toward the end of their 12-week therapy. The addition of a CGRPmAb could help in decreasing or eliminating these episodes, but this combination is considered "experimental" by many payers, which often leads to a denial of coverage. Currently, there is no reference in the literature or data to support the treatment of chronic migraine with OnabotulinumtoxinA and CGRPmAbs (Aimovig, Ajovy, Emgality or Vyepti) combination therapy. This has resulted in many patients and providers having to settle for one or the other. Investigators hopes to provide crucial data and findings to support the addition of CGRPmAb in some chronic migraine patients currently on monotherapy OnabotulinumtoxinA.

Conditions

Chronic Migraine, Headache

Outcome Measures

Primary Outcomes (1)

• Change in number of monthly migraine days with the addition of CGRPmAb Fremanezumab in chronic migraine patients currently on monotherapy OnabotulinumtoxinA.

  Change in number of monthly migraine days from baseline.

  6 months

Secondary Outcomes (1)

• To assess improvements in HIT-6 (Headache Impact Test) score of >5 point reduction with the addition of CGRPmAb Fremanezumab in chronic migraine patients currently on monotherapy OnabotulinumtoxinA.

  6 months

Study Arms (1)

Combination of Botox + CGRPmAb

EXPERIMENTAL

OnabotulinumtoxinA + Fremanezumab 225mg/1.5mL = 50

Drug: Combination of Botox + CGRPmAb (Fremanezumab 225mg/1.5mL)

Interventions

Combination of Botox + CGRPmAb (Fremanezumab 225mg/1.5mL) DRUG

OnabotulinumtoxinA + Fremanezumab 225mg/1.5mL

Combination of Botox + CGRPmAb

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic migraine patients between 18 to 75 years old
• Chronic migraine patients with ≥ 12-month history of migraine
• Participant has received at least 2 consecutive OnabotulinumtoxinA treatment at screening (visit 1)
• Achieved a clinically appropriate response from monotherapy OnabotulinumtoxinA at enrollment (visit 2):
• ≥50% reduction in mean monthly headache days of at least moderate severity OR Reduction of ≥7 mean monthly headache days of at least moderate severity OR
• HIT-6 reduction of ≥5 points
• History of ≥8 monthly migraine days (average from 3 previous months prior to enrollment (visit 2))

You may not qualify if:

• History of \<8 monthly migraine days (average from 3 previous months prior to enrollment (visit 2))
• Patients with current use, or use within 3 months prior to screening (visit 1) a CGRPmAbs (Aimovig, Ajovy, Emgality, or Vyepti)
• Concomitant use of gepants as a preventative treatment \< 1 week prior to screening (visit 1).
• Utilizing gepants as an acute rescue treatment \>5 days per month.
• Current user of recreational or illicit drugs, or a history within 1 year prior to screening (visit 1) of drug or alcohol abuse or dependence
• Clinically significant hematologic, endocrine, cardiovascular, pulmonary, gastrointestinal, or neurologic disease. If there is a history of such a disease, but the condition has been stable for more than 1 year prior to screening (visit 1) and is judged by the PI as not likely to interfere with participation in the study, the participant may be included.
• Female is pregnant, planning to become pregnant during the course of the study, or currently lactating.

Sponsors & Collaborators

• Chicago Headache Center & Research Institute: lead

Study Sites (1)

Chicago Headache Center & Research Institute

Chicago, Illinois, 60657, United States

Location

Related Publications (7)

• Goadsby PJ, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA. A Controlled Trial of Erenumab for Episodic Migraine. N Engl J Med. 2017 Nov 30;377(22):2123-2132. doi: 10.1056/NEJMoa1705848.

  PMID: 29171821 BACKGROUND

• Dodick DW, Ashina M, Brandes JL, Kudrow D, Lanteri-Minet M, Osipova V, Palmer K, Picard H, Mikol DD, Lenz RA. ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018 May;38(6):1026-1037. doi: 10.1177/0333102418759786. Epub 2018 Feb 22.

  PMID: 29471679 BACKGROUND

• Stauffer VL, Dodick DW, Zhang Q, Carter JN, Ailani J, Conley RR. Evaluation of Galcanezumab for the Prevention of Episodic Migraine: The EVOLVE-1 Randomized Clinical Trial. JAMA Neurol. 2018 Sep 1;75(9):1080-1088. doi: 10.1001/jamaneurol.2018.1212.

  PMID: 29813147 BACKGROUND

• Skljarevski V, Matharu M, Millen BA, Ossipov MH, Kim BK, Yang JY. Efficacy and safety of galcanezumab for the prevention of episodic migraine: Results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalalgia. 2018 Jul;38(8):1442-1454. doi: 10.1177/0333102418779543. Epub 2018 May 31.

  PMID: 29848108 BACKGROUND

• Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y, Aycardi E. Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial. JAMA. 2018 May 15;319(19):1999-2008. doi: 10.1001/jama.2018.4853.

  PMID: 29800211 BACKGROUND

• Ferrari MD, Diener HC, Ning X, Galic M, Cohen JM, Yang R, Mueller M, Ahn AH, Schwartz YC, Grozinski-Wolff M, Janka L, Ashina M. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet. 2019 Sep 21;394(10203):1030-1040. doi: 10.1016/S0140-6736(19)31946-4. Epub 2019 Aug 16.

  PMID: 31427046 BACKGROUND

• Blumenfeld AM, Frishberg BM, Schim JD, Iannone A, Schneider G, Yedigarova L, Manack Adams A. Real-World Evidence for Control of Chronic Migraine Patients Receiving CGRP Monoclonal Antibody Therapy Added to OnabotulinumtoxinA: A Retrospective Chart Review. Pain Ther. 2021 Dec;10(2):809-826. doi: 10.1007/s40122-021-00264-x. Epub 2021 Apr 21.

  PMID: 33880725 BACKGROUND

MeSH Terms

Conditions

Headache

Interventions

fremanezumab

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Managing Director

Model Details: Phase IV prospective open label interventional clinical study evaluating beneficial outcomes of the addition of CGRPmAb Fremanezumab in chronic migraine patients currently on monotherapy OnabotulinumtoxinA.

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 13, 2023
• Study Start: January 26, 2023
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

US (1)